Skip to main content
OpenTrials
Completed

NCT Number: NCT01930565

Effectiveness and Safety of New Botanical Component-LFCO- Compared With Existing TTO in Clinical Study

In an 8 week double blind randomized controlled split-face studies, we tried to compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)

Basically, this is a split face study - one side of face randomly assigned was applied with LFCO and the other side with TTO in same patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, Seoul National University College of Medicine

Seoul, 110-744, South Korea

About this study

Screening of natural compounds for the development of anti-acne therapeutic agents has been steadily required considering various side effects of acne medications.However, previous studies have mainly focused on experimental tests without clinical trials and histopathological analysis.

To compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)

Total thirty four patients were instructed to apply 5 % LFCO to the involved areas of randomly allocated side and 5 % TTO extract to the other side for 8 weeks in a double blind split-face clinical trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 19-45
  • active acne lesions in both sides of face
  • available during study periods

Exclusion criteria

  • pregnancy, mental illness, intake of oral isotretinoin within 6 months, application of the other oral or topical acne medications, chemical peeling or light based treatments within 6 weeks.

Treatment and study plan

LFCO application

Other

Application of LFCO (Lactobacillus fermented Chamaecypris obtusa ) containing creams to one randomly selected face of patients to monitor its effectiveness and safety of acne treatments.

Other names: LFCO containg creams applied to acne lesions

TTO application

Other

Application of TTO (Tea tree oil) containing creams to the other side of face of patients to monitor its effectiveness and safe compared with LFCO.

Other names: TTO containg creams applied to acne lesions

Primary outcomes

  1. Number of inflammatory and non-inflammatory acne lesions

    Time frame: total 8 weeks after baseline

    Compared to baseline, number inflammatory and non-inflammatory acne lesions were counted to check out the effectiveness & safety of two botanical compounds

Secondary outcomes

  1. Patient's subjective assessments for comfortableness & efficacy

    Time frame: 8 weeks after baseline

    Patients are required to report subjective assessments for comfortableness & efficacy for two creams they used

  2. Sebum secretion assessment

    Time frame: 8 weeks after baseline

    Patients' sebum secretion from face was measured by sebumeter to detect sebum secretion changes after applying two components.

  3. Histopathologic analysis

    Time frame: 8 weeks after baseline

    changes of tissue after application of two creams

  4. Adverse effects

    Time frame: 8 weeks after baseline

    patients' reportings for severe side effects after application of two creams was monitored.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison of Clinical and Histological Effects Between Lactobacillus Fermented Chamaecypris Obtusa and Tea Tree Oil for the Treatment of Mild to Moderate Acne: an 8-week Double Blind, Randomized Controlled, Split-face Study

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 29, 2013
Registry last updated
Aug 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.